Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070200
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2003-10-03
Brief Title:
Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Pilot Induction Regimen Incorporating Topotecan for Treatment of Newly Diagnosed High Risk Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as topotecan and cyclophosphamide use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE This phase I trial is studying the side effects of induction chemotherapy using cyclophosphamide and topotecan in treating patients who are undergoing surgery and autologous stem cell transplantation followed by radiation therapy for newly diagnosed or progressive neuroblastoma
PURPOSE This phase I trial is studying the side effects of induction chemotherapy using cyclophosphamide and topotecan in treating patients who are undergoing surgery and autologous stem cell transplantation followed by radiation therapy for newly diagnosed or progressive neuroblastoma
Detailed Description:
OBJECTIVES
Primary
Determine the toxicity and feasibility of adding cyclophosphamide and topotecan to induction therapy in patients with newly diagnosed or progressive high-risk neuroblastoma undergoing autologous peripheral blood stem cell PBSC transplantation
Determine the feasibility of PBSC mobilization and in vivo PBSC tumor purging in these patients after treatment with this regimen
Secondary
Determine tumor response rate in patients treated with this regimen
Determine the pharmacokinetics of this regimen in these patients
Determine whether topotecan affects cyclophosphamide pharmacokinetics in these patients
Correlate host DNA with toxicity and cyclophosphamide and topotecan pharmacokinetics in patients treated with this regimen
Determine toxicity in patients treated with this regimen
OUTLINE This is a pilot multicenter study Patients are stratified according to diagnosis newly diagnosed vs initially stage 1 2 or 4S that progressed to stage 4 without interval chemotherapy
Induction therapy Patients receive 6 courses of induction therapy
Courses 1 and 2 Patients receive cyclophosphamide IV over 30 minutes and topotecan IV over 30 minutes on days 1-5 and filgrastim G-CSF subcutaneously SC or IV beginning on day 6 and continuing until blood counts recover
Course 3 Patients receive etoposide IV over 2 hours on days 1-3 cisplatin IV over 1 hour on days 1-4 and G-CSF SC or IV beginning on day 5 and continuing until blood counts recover
Course 4 Patients receive cyclophosphamide IV over 6 hours on day 1 and doxorubicin IV and vincristine IV continuously over 24 hours on days 1-3 Patients also receive G-CSF SC or IV beginning on day 4 and continuing until blood counts recover
Course 5 Patients receive etoposide cisplatin and G-CSF as in course 3
Course 6 Patients receive cyclophosphamide doxorubicin vincristine and G-CSF as in course 4
Treatment repeats every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Consolidation therapy Within 4-6 weeks after completing induction therapy patients receive melphalan IV on days -7 to -5 and etoposide IV and carboplatin IV continuously over 24 hours on days -7 to -4
Stem cell transplantation Peripheral blood stem cells are collected after course 2 of induction therapy and infused on day 0 Patients receive G-CSF IV beginning on day 0 and continuing until blood counts recover
Surgery After course 5 of induction therapy patients undergo surgery
Radiotherapy Beginning 28-42 days after transplantation patients receive 12 fractions of local radiotherapy to all areas of residual soft tissue disease and the primary tumor site even if completely resected
Maintenance therapy Beginning 66 days after transplantation patients receive oral isotretinoin twice daily on days 1-14 Treatment repeats every 28 days for a total of 6 courses
Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 10-29 patients will be accrued for this study within 2 years
Primary
Determine the toxicity and feasibility of adding cyclophosphamide and topotecan to induction therapy in patients with newly diagnosed or progressive high-risk neuroblastoma undergoing autologous peripheral blood stem cell PBSC transplantation
Determine the feasibility of PBSC mobilization and in vivo PBSC tumor purging in these patients after treatment with this regimen
Secondary
Determine tumor response rate in patients treated with this regimen
Determine the pharmacokinetics of this regimen in these patients
Determine whether topotecan affects cyclophosphamide pharmacokinetics in these patients
Correlate host DNA with toxicity and cyclophosphamide and topotecan pharmacokinetics in patients treated with this regimen
Determine toxicity in patients treated with this regimen
OUTLINE This is a pilot multicenter study Patients are stratified according to diagnosis newly diagnosed vs initially stage 1 2 or 4S that progressed to stage 4 without interval chemotherapy
Induction therapy Patients receive 6 courses of induction therapy
Courses 1 and 2 Patients receive cyclophosphamide IV over 30 minutes and topotecan IV over 30 minutes on days 1-5 and filgrastim G-CSF subcutaneously SC or IV beginning on day 6 and continuing until blood counts recover
Course 3 Patients receive etoposide IV over 2 hours on days 1-3 cisplatin IV over 1 hour on days 1-4 and G-CSF SC or IV beginning on day 5 and continuing until blood counts recover
Course 4 Patients receive cyclophosphamide IV over 6 hours on day 1 and doxorubicin IV and vincristine IV continuously over 24 hours on days 1-3 Patients also receive G-CSF SC or IV beginning on day 4 and continuing until blood counts recover
Course 5 Patients receive etoposide cisplatin and G-CSF as in course 3
Course 6 Patients receive cyclophosphamide doxorubicin vincristine and G-CSF as in course 4
Treatment repeats every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Consolidation therapy Within 4-6 weeks after completing induction therapy patients receive melphalan IV on days -7 to -5 and etoposide IV and carboplatin IV continuously over 24 hours on days -7 to -4
Stem cell transplantation Peripheral blood stem cells are collected after course 2 of induction therapy and infused on day 0 Patients receive G-CSF IV beginning on day 0 and continuing until blood counts recover
Surgery After course 5 of induction therapy patients undergo surgery
Radiotherapy Beginning 28-42 days after transplantation patients receive 12 fractions of local radiotherapy to all areas of residual soft tissue disease and the primary tumor site even if completely resected
Maintenance therapy Beginning 66 days after transplantation patients receive oral isotretinoin twice daily on days 1-14 Treatment repeats every 28 days for a total of 6 courses
Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 10-29 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000330140 | OTHER | None | None |
| COG-ANBL02P1 | OTHER | Childrens Oncology Group | None |